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Sponsors and Collaborators: |
University of Illinois National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450957 |
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of lycopene in healthy male participants.
Condition | Intervention | Phase |
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Healthy, no Evidence of Disease Prostate Cancer |
Dietary Supplement: dietary intervention Dietary Supplement: lycopene Other: pharmacological study Other: preventative dietary intervention |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized |
Official Title: | Phase I Multiple Dose Pharmacokinetic Study of the Dietary Supplement Lycopene Delivered in Capsule Form to Healthy Male Volunteers Between 18 and 55 Years of Age |
Estimated Enrollment: | 20 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a randomized, crossover study. Participants are randomized to 1 of 2 treatment arms.
Treatment continues in the absence of unacceptable toxicity.
Participants adhere to dietary restrictions for 2 weeks at baseline, 2 weeks during study treatment, and 2 weeks during pharmacokinetic sampling.
Blood samples are collected periodically at baseline and during study treatment for pharmacokinetic studies.
PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
No active history of any of the following:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
University of Illinois Cancer Center | |
Chicago, Illinois, United States, 60612-7243 |
Principal Investigator: | Keith A. Rodvold | University of Illinois |
Study ID Numbers: | CDR0000536181, UIC-2006-0853 |
Study First Received: | March 20, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00450957 History of Changes |
Health Authority: | United States: Food and Drug Administration |
prostate cancer healthy, no evidence of disease |
Anticarcinogenic Agents Radiation-Protective Agents Antioxidants Prostatic Diseases Genital Neoplasms, Male |
Lycopene Urogenital Neoplasms Healthy Genital Diseases, Male Prostatic Neoplasms |
Anticarcinogenic Agents Radiation-Protective Agents Antioxidants Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Lycopene Physiological Effects of Drugs |
Urogenital Neoplasms Genital Diseases, Male Protective Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |